- Danaher Corporation (Vista, CA)
- …and Development and Regulatory Affairs on deliverables for global regulatory submissions, including FDA pre-submissions, 510k, and IVDR CE certifications ... + Participate in the performance and documentation of internal and external audits and respond to audit findings by proposing and implementing necessary corrective actions The essential requirements of the job include: + BS/BA in Engineering or a technical… more
- IQVIA (Valencia, CA)
- …capabilities to meet deadlines and deliverables + Proficiency in laboratory terminology and regulatory standards including FDA , GLP, ICH, ISO HL7 + Excellent ... + Perform and document analytical procedures in accordance with SOPs and regulatory guidelines. + Conduct routine data analysis, identifying potential errors and… more
- Chipotle Mexican Grill (Newport Beach, CA)
- …and professional groups such as CPS, LGMA, etc. + Accustomed to working with FDA , USDA, State and Local Regulatory Agencies. + Bilingual in English/Spanish ... preferred + Proven ability to develop and implement programs that improve food safety and quality monitoring. + Ability to analyze data, perform statistical analysis, proficient in MS Office. + Self-starter: has the motivation, discipline, and mindset to get… more
- Sharp HealthCare (San Diego, CA)
- …follow through, and prevention.Assists in maintaining CAP, JCAHO, CA state, AABB, FDA , and other accreditation and regulatory agency standards and ... regulations.Demonstrates emotional intelligence, critical thinking, and logical decision-making, especially under critical and stressful situations, to reach acceptable resolutions. + Test processes by evaluating quality control systems, data and… more
- Actalent (Camarillo, CA)
- …+ Excellent interpersonal skills. + Thorough understanding of industry standards and regulatory guidelines (cGMP, FDA , etc.) preferred. + Thorough understanding ... of applicable mathematics, statistical, and scientific practices. + Thorough understanding of related equipment and the ability to perform equipment modifications. + Proficient with Microsoft Office Suite or related software. Additional Skills & Qualifications… more
- Oracle (Sacramento, CA)
- …**Oracle Cloud SCM, Manufacturing, Quality, and ERP** integrations. + Knowledge of ** regulatory compliance processes** ( FDA , ISO, cGMP) and quality documentation ... management. + Familiarity with **Oracle Visual Builder Studio** , **BI Publisher** , and **Reports** for PLM analytics. + Certification in **Oracle Cloud PLM or PDH** modules. + Strong understanding of **product data governance frameworks** and enterprise data… more
- Lactalis American Group Inc. (Tulare, CA)
- …with state and federal regulations. + Maintains facility and assets to meet regulatory guidelines (USDA, FDA , OSHA, EPA). + Develops preventative maintenance ... procedures that are cost effective and increase the operational life of the equipment. + Partners with the Maintenance Manager to evaluate long-term needs in relation to major projects and plant improvements. Assists with the development of the capital program… more
- Kelly Services (Petaluma, CA)
- …scale and manage the QA team; hire and mentor quality staff + Ensure regulatory compliance with GMP, FDA , ISO13485 and combination product requirements + Oversee ... analysis, CAPA programs, and continuous improvement. + Engage with R&D, manufacturing, and regulatory teams to align quality and business goals What We Are Looking… more
- Imperative Care (Campbell, CA)
- …risk analysis, and implement electrical safety design and documentation that complies with regulatory requirements of the FDA , UL and TUV (specifically those ... of product hardware and identify design improvements to ensure compliance with regulatory standards such as IEC60601-1, IEC60601-1-2, CISPR22, ISO for safety and EMC… more
- Terumo Neuro (Aliso Viejo, CA)
- …+ Supports preparation and hosting activities for third party audits including FDA , Notified Body, corporate and international regulatory authorities' audits. ... to maintaining and improving quality systems to ensure compliance with global regulatory requirements and ensuring that the quality systems are used effectively to… more